SPL v1
SPL
SPL Set ID 80e07a95-6249-49b2-8610-c430b9fcd5b4
Route
TOPICAL
Published
Effective Date 2010-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Titanium Dioxide (2.2 g) Enzacamene (2.0 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-21

Description

Active Ingredients: Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Benzophenone-3


Medication Information

Description

Active Ingredients: Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Benzophenone-3

Section 42232-9
Caution:

- Be careful it may be slippery when contact with the product

- Be careful not to make contact with clothes

- Be careful not to give a shock since the container may be broken and get injured

Section 44425-7
Storage and Handling:

- To keep the freshness, please close the lid after the use

- Do not store this product in a place of high or low temperature

- Do not expose it to the direct sunlight

Section 50565-1
Keep this and all drugs out of reach of children

Section 50567-7
Directions:

When you use or do leisure, apply reasonable amount on your body exposed to UV including face, neck, arms and legs at your finishing step of basic makeup.  Take more frequent reapplication for long time outdoor activities

Section 50570-1
Notice for Use:

1. Discontinue if the following symptom appears and consult with dermatologist for the continuous problem of use

a) Discontinue use if redness, rash, irritation or tingling appears

b) Discontinue if the above symptom appears by a direct sunlight on the applied part

2. Avoid the part for a cut, eczema or dermatitis

Section 51727-6
Inactive Ingredients:

Water, Cyclopentasiloxane, Disteardimonium Hectorite, Dimethiconol, Tocopheryl Acetate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Glyceryl Behenate/Eicosadioate, Cetyl Ethylhexanoate, Cyclohexasiloxane, Propylene Glycol, Dipropylene Glycol, Allantoin, Aluminum Hydroxide, Stearic Acid, Xanthan Gum, Methylparaben, Sodium Chloride, Butylparaben, Imidazolidinyl Urea, Fragrance, Ethylparaben, Oryza Sativa (Rice) bran Oil, Oryza Sativa (Rice) Bran Extract

Section 51945-4
Section 55106-9
Active Ingredients:

Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Benzophenone-3


Structured Label Content

Section 42232-9 (42232-9)
Caution:

- Be careful it may be slippery when contact with the product

- Be careful not to make contact with clothes

- Be careful not to give a shock since the container may be broken and get injured

Section 44425-7 (44425-7)
Storage and Handling:

- To keep the freshness, please close the lid after the use

- Do not store this product in a place of high or low temperature

- Do not expose it to the direct sunlight

Section 50565-1 (50565-1)
Keep this and all drugs out of reach of children

Section 50567-7 (50567-7)
Directions:

When you use or do leisure, apply reasonable amount on your body exposed to UV including face, neck, arms and legs at your finishing step of basic makeup.  Take more frequent reapplication for long time outdoor activities

Section 50570-1 (50570-1)
Notice for Use:

1. Discontinue if the following symptom appears and consult with dermatologist for the continuous problem of use

a) Discontinue use if redness, rash, irritation or tingling appears

b) Discontinue if the above symptom appears by a direct sunlight on the applied part

2. Avoid the part for a cut, eczema or dermatitis

Section 51727-6 (51727-6)
Inactive Ingredients:

Water, Cyclopentasiloxane, Disteardimonium Hectorite, Dimethiconol, Tocopheryl Acetate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Glyceryl Behenate/Eicosadioate, Cetyl Ethylhexanoate, Cyclohexasiloxane, Propylene Glycol, Dipropylene Glycol, Allantoin, Aluminum Hydroxide, Stearic Acid, Xanthan Gum, Methylparaben, Sodium Chloride, Butylparaben, Imidazolidinyl Urea, Fragrance, Ethylparaben, Oryza Sativa (Rice) bran Oil, Oryza Sativa (Rice) Bran Extract

Section 51945-4 (51945-4)
Section 55106-9 (55106-9)
Active Ingredients:

Ethylhexyl Methoxycinnamate, Titanium Dioxide, 4-Methylbenzylidene Camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Benzophenone-3


Advanced Ingredient Data


Raw Label Data

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